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Cometriq and Pregnancy

Women of childbearing age who are going to receive Cometriq (cabozantinib) should use an effective form of birth control during treatment. When given to pregnant animals, this drug caused a number of problems, such as miscarriages and abnormal bone development. As a Category D medicine, it should only be given to a pregnant woman when the benefits outweigh the risks.

 

Can Pregnant Women Take Cometriq?

Cometriq™ (cabozantinib) is a prescription medication approved to treat a rare type of thyroid cancer known as medullary thyroid cancer. Based on studies in animals, this medication may harm an unborn child if taken by a pregnant woman.
 

What Is Pregnancy Category D?

The U.S. Food and Drug Administration (FDA) uses a category system to classify the possible risks to a fetus when a specific medicine is taken during pregnancy. Cometriq is classified as a pregnancy Category D medicine.
 
Pregnancy Category D is a classification given to medicines that have been shown to present a risk to the fetus in studies of pregnant women but may still offer benefits that outweigh the risks the drug presents. A pregnancy Category D medicine may still be given to a pregnant woman if her healthcare provider believes that the benefits to the woman outweigh the possible risks to her unborn child.
 
When Cometriq was given to pregnant rats, it increased the risk for miscarriage, as well as abnormal bone development in the fetal rats. These problems occurred even at doses that were lower than the normally recommended human dose. When given to pregnant rabbits, the drug reduced the size of the spleen and caused lung defects in the developing rabbits. Cometriq has not been studied in pregnant women.
 
If you are a woman of childbearing potential, you should use an effective form of birth control during treatment with Cometriq, and for at least four months after your last dose. Men with female partners of childbearing potential should also use effective birth control while taking this drug and for at least four months after treatment ends. Talk to your healthcare provider about the best birth control options for your particular situation.
 
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